Glossary

Validation

In many regulations and laws, especially in the manufacture of pharmaceutical products, the validation of processes is required wherever processes are supposed to provide a reproducible product according to previously specified requirements. Methods are standardised and validated in order to ensure that a method reliably produces the expected result within defined limits (specifications). Corresponding proofs must be documented. Validation includes systematic checking of installations, equipment and processes to ensure that they are suitable for the intended purpose.

Sympatec provides a comprehensive documention for validation as an add-on to support the qualification of the installations in a validated (mainly pharmaceutical) environment. Therefore, a Validation Binder contains all documents created during production, system integration and on-site installation.

Chapter 1

Sympatec’s Validation Procedure

Chapter 2

Installation Qualification (IQ) 

  • Check of general operating conditions, including supplies and environment
  • Verification of the proper installation of all delivered components, identified by their serial numbers
  • Software validation by a check list of all installed files and Windows® registry entries

Chapter 3

Operational Qualification (OQ) 

  • Check of the manual and remote controlled functionality, communication and data evaluation
  • Verification of the proper function of all delivered components

Chapter 4

Performance Qualification (PQ) 

  • Check of the entire system under realistic operating conditions with the help of  reference materials

Chapter 5

Production Binder 

  • Copies of the documents generated during the production of the system components

Chapter 6

Production Operational Qualification 

  • Copies of the performed circuit board and functional tests of the components after assembly

Chapter 7

Production Performance Qualification

  • Check of the entire system under realistic operating conditions with the help of  reference materials
Quality

Sympatec's Quality Management System is primarily designed to get the optimum performance and best system-to-system reproducibility of all our particle sizing instruments under real conditions.